MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-08-10 for SUPER SOOTHIE PACIFIER Y4378 manufactured by Learning Curve.
[16166282]
A (b)(4) child was brought into our emergency room via ambulance with a super soothie pacifier wedged in her hypopharynx-posterior mouth-. Extraction was attempted by physician and respiratory therapist using magill forceps. These attempts were unsuccessful as they kept slipping off of the pacifier. Our surgeon arrived. He attempted to extract the pacifier with the magill and was also unsuccessful. The surgeon was able to use a tongue blade and push the tongue out of the way so he could clamp down on the pacifier using a kocher clamp and was able to extract the pacifier. The patient remained on oxygen and was placed in observation care for a few hours of continued monitoring to watch for throat swelling and airway compromise. The patient was released from the hospital four hours after the event in the care of her parents. The baby did suffer a few scrapes in her throat but no permanent damage was noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5017071 |
| MDR Report Key | 1802840 |
| Date Received | 2010-08-10 |
| Date of Report | 2010-08-10 |
| Date of Event | 2010-08-05 |
| Date Added to Maude | 2010-08-19 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPER SOOTHIE PACIFIER |
| Generic Name | SOOTHIE |
| Product Code | LQX |
| Date Received | 2010-08-10 |
| Model Number | Y4378 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEARNING CURVE |
| Manufacturer Address | 1111 W 22ND ST SUITE 320 OAK BROOK IL 60523 US 60523 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Deathisabilit | 2010-08-10 |